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Brief Title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Official Title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Study ID: NCT00526305
Brief Summary: Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.
Detailed Description: Remission Induction: * Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 * Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8. * Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14 * L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13 Results: 1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks 2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C Intrathecal chemotherapy: Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22 CONSOLIDATION TREATMENT 1 Start in two weeks after last dose of induction chemotherapy: * Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63 * Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56. * VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42 * ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43 * Intrathecal treatment, days 28 and 56. 6.4. CONSOLIDATION TREATMENT 2 Start in a week after last dose of mercaptopurine of previous cycle * Dexamethasone (DXM): * 10 mg/m2 day, p.o. or i.v. days 1-14 * 5 mg/m2 day, p.o. or i.v., days 15-21 * Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15 * Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9. * CFM 600 mg/m2 day, i.v., days 1 and 15 * L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17 * Intrathecal treatment days 1 and 15. TRANSPLANTATION Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment. Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1 Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Central de Asturias, Oviedo, Asturias, Spain
Hospital general de Castellón, Castello, Castellón, Spain
Hospital de Navarra, Pamplona, Navarra, Spain
Hospital Verge de la Cinta, Tortosa, Tarragona, Spain
Complejo Hospitalario Universitario de Albacete, Albacete, , Spain
Hospital General de Alicante, Alicante, , Spain
Hospital Ntra. Sra. Sonsoles, Avila, , Spain
Hospital de Badalona Germans Trias i Pujol, Badalona, , Spain
Hospital Clínic, Barcelona, , Spain
Hospital de Sant Pau, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital vall d'Hebrón, Barcelona, , Spain
Basurtuko Ospitalea, Basurto, , Spain
Hospital de Cruces, Bilbao, , Spain
Hospital de Jerez de la Frontera, Jerez de La Frontera, , Spain
Complejo Hospitalario León, Leon, , Spain
Hospital Arnau de Vilanova, Lleida, , Spain
Complexo Hospitalario Xeral-Calde, Lugo, , Spain
Clínica Puerta de Hierro, Madrid, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Hospital Clínico San Carlos de Madrid, Madrid, , Spain
Hospital de la Princesa, Madrid, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, Madrid, , Spain
Hospital Universitario de la Princesa, Madrid, , Spain
Althaia, Xarxa Asistencial de Manresa, Manresa, , Spain
Hospital General Morales Meseguer, Murcia, , Spain
Hospital General Universitario Morales Meseguer., Murcia, , Spain
Hospital Santa María del Rosell, Murcia, , Spain
. Hospital Clínico Universitario Virgen de la Victoria, Málaga, , Spain
H. Carlos Haya, Málaga, , Spain
Complejo Asistencial Son Dureta, Palma de Mallorca, , Spain
Hospital Son Llatzer, Palma de Mallorca, , Spain
Clínica Universitaria de Navarra, Pamplona, , Spain
Complejo Hospitalario de Pontevedra_Hospital Montecelo, Pontevedra, , Spain
Corporació Sanitaria Parc Taulí, Sabadell, , Spain
Hospital de Sagunto, Sagunto, , Spain
Hospital Clínico Universitario de Salamanca, Salamanca, , Spain
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, , Spain
Hospital General de Segovia, Segovia, , Spain
H.U. Virgen del Rocio, Sevilla, , Spain
Hospital Universitario de Canarias, Tenerife, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Clínic, Valencia, , Spain
Hospital dr. Peset, Valencia, , Spain
Hospital General Universitario, Valencia, , Spain
Hospital La Fe, Valencia, , Spain
Hospital Clínico de Valladolid, Valladolid, , Spain
Complejo Hospitalario Universitario de Vigo, Vigo, , Spain
Hospital de Galdakao, Vizcaya, , Spain
Hospital Clínico Lozano Blesa, Zaragoza, , Spain
Name: Ribera Josep Mª, Dr
Affiliation: Germans Trias i Pujol Hospital
Role: STUDY_CHAIR